This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.
In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.
Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.
Male or female, between the ages of 18 to 80 years at screening, both inclusive.
Subjects voluntarily consenting for participation in the study and having signed informed consent document. Subjects are required to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available.
Body mass index (BMI) between 19 to 42 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2). Subjects must have two feet. Each foot must have five digits. Each foot must have at least total surface area of 450 cm2 measured from below the ankle to the toes including both dorsum and plantar areas.
The subject is diagnosed with Type 1 or Type 2 diabetes, and has a history of DPNP for at least 3 months based on participant report or medical history.
Current participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.
History of clinically significant drug, food allergy, skin allergy, or sensitivity to drugs of the same class (e.g., 5-aminosalicylic acid, sulfasalazine, and salicylates) or known hypersensitivity to YJ001 or any of its components.
History of asthma. Adults with history of benign (resolved) childhood asthma may be included.
Any subject who suffers severe peripheral vascular disease (e.g., intermittent claudication) at screening, and is not suitable to be involved in the study as per investigator evaluation.
Parallel
YJ001 for Spray Use
DrugGranules for spray use; Preparation of Dosing Solution: Reconstitute with sterile water (50ml)
Placebo of YJ001 for Spray Use
DrugInactive Ingredient: Sterile water; Preparation of Dosing Solution: 50ml Sterile water
Safety Assessments - AEs
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Safety Assessments -Number of Participants With Abnormal Laboratory Values
Observed values and changes in baseline of clinical safety laboratory parameters
Safety Assessments - Skin Reaction
Administration site assessment
Pharmacokinetics-AUC
Pharmacokinetics of YJ001 and metabolites YJ001-A, YJ001-B, and YJ001-C will be evaluated. Area under the concentration-time curve (AUC)
Pharmacokinetics- Cmax
Maximum observed plasma concentration post dose (Cmax)
Pharmacokinetics - tmax
Time of maximum observed plasma concentration (tmax)
Pharmacokinetics - tlag
Time to first quantifiable plasma concentration (tlag)
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